NCT07278531Not yet recruiting
Adaptive Dietary Intervention (ADI) for Asian Americans With Type 2 Diabetes
Adaptive Dietary Intervention (ADI) Leveraging Continuous Glucose Monitoring for Asian Americans With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
The investigators will examine the feasibility, acceptability, and effect of an adaptive dietary intervention over 24 weeks (12-week intervention, 12-week follow-up) among Asian Americans with Type 2 diabetes. Participants (N=120; 60 Chinese Americans and 60 Vietnamese Americans) will be 2:1 randomized to one of two arms: adaptive dietary intervention or standard of care (SC). The intervention will begin with continued glucose monitoring (CGM) use only during weeks 0-4. At week 4, participants who achieve the glycemic control goal (at least an 8% increase in time in range \[TIR\] from baseline) will continue with the CGM alone during weeks 4-12 ("CGM Alone"); otherwise, culturally and linguistically adapted glucose excursion minimization (GEM) will be augmented with CGM ("CGM-GEM").
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 3 Dec 2025
- Start date
- Feb 2027
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- NYU Langone Health
- Diseases
- Type 2 diabetes
- NCT number
- NCT07278531
What you commit to
- Study type: Interventional
- Planned participants: 120
- From Feb 2027 to the primary completion date, 31 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking hypoglycemia agents (e.g., insulin and sulfonylureas) with the major side effect of hypoglycemia that need close monitoring the occurrence of hypoglycemia to adjust/reduce medications to avoid future hypoglycemia.
- Taking medications that impede weight loss (e.g., prednisone) within the last 3 months.
- Are prior or current CGM users including both Dexcom and FreeStyle Libre and plan to continuously use these CGMs in the next 6 months.
Other illness
- Have serious physical complications (e.g., severe neuropathy cardiovascular disease, COPD/emphysema, osteoarthritis, or stroke) or mental disease (e.g., schizophrenia, bipolar disorder, manic depressive illness, severe depression, or active substance abuse).
- Have conditions that restrict diet, such as severe gastroparesis, ulcers, or food allergies. These conditions may need special dietary intervention.
Lab values
- Undergoing treatment for cancer, as cancer treatment may impact the outcome of glucose changes.
- Have marked renal impairment (eGRF\<45; CKD-3b), as renal impairment may needs special dietary intervention and they also may impact glucose changes.
- Are taking psychotropic medications that raise blood glucose (e.g., atypical antipsychotics).
Other
- Currently pregnant, breastfeeding, or contemplating pregnancy within the next 6 months.
- Are participating in another T2D intervention study.
Who the study is looking for
- Eligible participants (N=120; 60 Chinese Americans and 60 Vietnamese Americans)
- Community-dwelling adults aged ≥ 18 with independent living;
- Diagnosed with T2D;
- Hb1Ac\>7.0%
- Self-identified as first- or second-generation Chinese or Vietnamese immigrants;
- Able to communicate in English, Chinese, or Vietnamese. We will focus on Mandarin-, Cantonese- or English-speaking Chinese Americans because the two best-known and most-spoken variants of Chinese are Mandarin and Cantonese, who use the same writing system;
- Have a smartphone, iPad, tablet, or Apple watch
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.